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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000046539 |
Receipt No. | R000053088 |
Scientific Title | Physical and mental effects of foot-bath among women in labor: A pre-post-test experimental design |
Date of disclosure of the study information | 2022/01/17 |
Last modified on | 2022/01/05 |
Basic information | ||
Public title | Physical and mental effects of foot-bath among women in labor | |
Acronym | The effects of foot-bath among women in labor | |
Scientific Title | Physical and mental effects of foot-bath among women in labor: A pre-post-test experimental design | |
Scientific Title:Acronym | The effects of foot-bath among women in labor: A pre-post-test experimental design | |
Region |
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Condition | ||
Condition | Women in labor | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the physical and mental effects of foot-bath using biomarker and self-administered questionnaire. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The salivary cortisol levels immediately after foot-bath |
Key secondary outcomes | The levels of relaxation, comfort, labor pain, warmth of body, vital signs, and interval of labor pain immediately after foot-bath |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | For women in the first stage of labor, implement a foot-bath for 15 to 20 minutes using a foot-bath machine. The temperature of the hot water should be in the range of 38 to 42 degree Celsius, which is set to a temperature that the women feels comfortable with. During the foot-bath, do not apply any stimuli such as pushing the acupoints or massaging. | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | Women in the first stage of labor or induction of labor. | |||
Key exclusion criteria | Women who can not answer the questionnaire of have difficulty participating in the study. | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Dokkyo Medical University | ||||||
Division name | Graduate Program of Midwifery | ||||||
Zip code | 321-0293 | ||||||
Address | 880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi | ||||||
TEL | 0282-86-1111 | ||||||
a-isoyama@dokkyomed.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Dokkyo Medical University | ||||||
Division name | Graduate Program of Midwifery | ||||||
Zip code | 321-0293 | ||||||
Address | 880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi | ||||||
TEL | 0282-86-1111 | ||||||
Homepage URL | |||||||
nhikita-tky@umin.ac.jp |
Sponsor | |
Institute | Dokkyo Medical University |
Institute | |
Department |
Funding Source | |
Organization | Dokkyo Medical University |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Dokkyo Medical University |
Address | 880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi |
Tel | 0282-86-1111 |
soumu@dokkyomed.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053088 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |